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Table 4 Multivariable determinants of outcome in the Zoledronate versus Ibandronate Comparative Evaluation (ZICE) trial (odds of experiencing a skeletal-related event during the first 12 months)

From: The use of randomisation-based efficacy estimators in non-inferiority trials

Variable Adjusted odds ratio 95% Confidence interval p value
Lower Upper
Gender (female compared to male) 0.23 0.06 0.88 0.032
18.5 kg/m2 < BMI ≤ 25 kg/m2 (normal/healthy weight) compared to ≤ 18.5 kg/m2 (underweight) 6.16 0.75 50.65 <0.001
25 kg/m2 < BMI ≤ 30 kg/m2 (overweight) compared to ≤ 18.5 kg/m2 (underweight) 6.85 0.84 56.13
30 kg/m2 < BMI ≤ 35 kg/m2 (moderately obese) compared to ≤ 18.5 kg/m2 (underweight) 13.17 1.59 108.81
35 kg/m2 < BMI ≤ 40 kg/m2 (severely obese) compared to ≤ 18.5 kg/m2 (underweight) 6.99 0.81 60.39
BMI > 40 kg/m2 (very severely obese) compared to ≤ 18.5 kg/m2 (underweight) 13.11 1.44 119.65
QLQ-C30 global health domain (per unit increase) 0.98 0.98 0.99 0.001
QLQ-C30 role functioning domain (per unit increase) 1.01 1.00 1.02 0.005
QLQ-C30 nausea / vomiting domain (per unit increase) 1.01 1.01 1.02 <0.001
QLQ-C30 dyspnoea domain (per unit increase) 0.99 0.99 1.00 0.056
SRE within the three months prior to baseline compared to no SRE within three months prior to baseline 1.56 1.14 2.13 0.006
Recent use of pain medication at baseline compared to no recent use of pain medication 1.63 1.08 2.46 0.019